Agency classClass IIOur severity:Severe FDA (Drugs)·D-0425-2015·Announced 2015-04-01

Baxter Recalls Sodium Chloride Injection Due to Sterility Concerns

Baxter Healthcare is recalling 0.9% Sodium Chloride Injection due to reports of missing closures and leaks that may compromise sterility.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a potential loss of sterility in an intravenous product, which poses a significant risk of serious injury or infection.

Plain-English summary

Baxter Healthcare Corp. is recalling 0.9% Sodium Chloride Injection, USP, 500 mL in VIAFLEX Plastic Container. The recall involves approximately 597,498 units distributed nationwide. The affected lots are C929844 (Exp 5/31/2015), C926873 (Exp 4/30/2015), and C928630 (Exp 4/30/2015).

The recall was initiated because complaints were received regarding missing closures and/or leaks in the product containers. These defects may compromise the sterility of the injection, which is a critical safety requirement for intravenous medications.

Healthcare providers and facilities that have received this product should stop using the affected lots and contact Baxter Healthcare for instructions on return or disposal. Patients who have received the product should consult their healthcare provider if they have concerns.

The recalled product

Product: SODIUM CHLORIDE (SODIUM CHLORIDE)
Brand: SODIUM CHLORIDE
Manufacturer: Baxter Healthcare Corp.
Category: Drug — IV Fluids
Hazard: sterility-compromise
packaging-defect
Affected units: 597,498

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (6)

Lot #: C929844
Exp 5/31/2015
C926873
Exp 4/30/2015
C928630
Exp 4/30/2015.

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by Baxter Healthcare Corp. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Same brand · SODIUM CHLORIDE

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Baxter Recalls Sodium Chloride Injection Bags Due to Fiberglass Particulates
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Spectra sodium chloride ampules recalled over lack of sterility assurance
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Fresenius Kabi half-normal saline 250 mL bags recalled over sterility assurance
FDA (Drugs) · 2026-04-15
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Fresenius Kabi 250 mL sodium chloride injection recalled over sterility assurance
FDA (Drugs) · 2026-04-15

Same manufacturer · Baxter Healthcare Corp.

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Same hazard · sterility compromise